Comparison of the Effectiveness of Intraoperative Intravenous Lidocaine and Intravenous Remifentanil in Postoperative Pain Management in Laparoscopic Cholecystectomy

NCT07312877 | Completed

• 1 other identifier: NG269436444.
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of intraoperative intravenous lidocaine and intravenous remifentanil on postoperative pain management in patients undergoing laparoscopic cholecystectomy under general anesthesia. Although laparoscopic procedures are minimally invasive, patients frequently experience postoperative pain. Multimodal analgesia techniques are recommended to optimize pain control and recovery while minimizing opioid-related adverse effects. In this prospective observational study, adult patients (ASA I-II) aged over 18 years who provided written informed consent were included. Standard intraoperative monitoring was performed. Anesthesia induction consisted of fentanyl, lidocaine, propofol, and rocuronium, with maintenance using sevoflurane. Hemodynamic parameters were recorded throughout the procedure. For postoperative analgesia, intravenous paracetamol and tramadol were administered before the end of anesthesia. The primary objective is to evaluate whether intravenous lidocaine provides postoperative analgesic efficacy and recovery quality comparable to remifentanil, and to determine its potential role as an opioid-sparing alternative in laparoscopic cholecystectomy.

Conditions

Colicystitis

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (NRS)

  Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain scores will be recorded at rest at 1, 6, 12, and 24 hours after surgery. The comparison between the lidocaine and remifentanil groups will determine the effect of intraoperative intravenous lidocaine versus remifentanil on postoperative analgesia.

  Within 24 hours after surgery

Secondary Outcomes (6)

• Heart Rate

  Intraoperative period

• Mean Arterial Pressure

  Intraoperative period

• Systolic Blood Pressure

  Intraoperative period

• Diastolic blood Pressure

  Intraoperative period

• Recovery Profile

  Immediate postoperative period

Study Arms (2)

Lidocaine Group

Patients received IV lidocaine (1 mg/kg bolus + infusion) during laparoscopic cholecystectomy

Drug: Lidocaine

Remifentanil Group

Patients received IV remifentanil infusion during laparoscopic cholecystectomy

Drug: Remifentanil

Interventions

Lidocaine DRUG

Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.

Lidocaine Group

Remifentanil DRUG

Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.

Remifentanil Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia at Prof. Dr. Cemil Taşçıoğlu City Hospital.

You may qualify if:

• Patients over 18 years of age
• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Provided written and verbal informed consent

You may not qualify if:

• Allergy or contraindication to lidocaine, remifentanil, or study drugs
• Severe cardiovascular, hepatic, or renal disease
• Pregnancy or lactation
• Conversion from laparoscopic to open cholecystectomy
• Refusal to participate

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascıoğlu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine; Remifentanil

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: April 1, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)